A5067541368- Skin Protection and Aging
- Asthma and respiratory diseases
- Respiratory and Cough-Related Research
- Bee Products Chemical Analysis
- Poisoning and overdose treatments
- Respiratory Support and Mechanisms
- Advancements in Transdermal Drug Delivery
- Chronic Obstructive Pulmonary Disease (COPD) Research
- Pesticide Exposure and Toxicity
- Pesticide Residue Analysis and Safety
- Pituitary Gland Disorders and Treatments
- Delphi Technique in Research
- Foreign Body Medical Cases
- Burn Injury Management and Outcomes
- Vasculitis and related conditions
- Inhalation and Respiratory Drug Delivery
- Pharmaceutical studies and practices
- Neuroscience of respiration and sleep
- Nonmelanoma Skin Cancer Studies
- Olfactory and Sensory Function Studies
- Contact Dermatitis and Allergies
- Hemodynamic Monitoring and Therapy
- Sarcoidosis and Beryllium Toxicity Research
- Cutaneous Melanoma Detection and Management
- Allergic Rhinitis and Sensitization
Center for Drug Evaluation and Research
2013-2023
United States Food and Drug Administration
2019-2023
Merck & Co., Inc., Rahway, NJ, USA (United States)
2001-2002
Johns Hopkins Medicine
1999
Johns Hopkins University
1994-1999
Johns Hopkins Hospital
1994
Background. The greatest prevalence of asthma is in preschool children; however, the clinical utility therapy for this age group limited by a narrow therapeutic index, long-term tolerability, and frequency and/or difficulty administration. Inhaled corticosteroids inhaled cromolyn are most commonly prescribed controller therapies young children with persistent asthma, although very patients may have using inhalers, dose delivery can be variable. Moreover, reduced compliance relative to orally...
<h3>Importance</h3> The US Food and Drug Administration (FDA) has provided guidance that sunscreen active ingredients with systemic absorption greater than 0.5 ng/mL or safety concerns should undergo nonclinical toxicology assessment including carcinogenicity additional developmental reproductive studies. <h3>Objective</h3> To determine whether the (avobenzone, oxybenzone, octocrylene, ecamsule) of 4 commercially available sunscreens are absorbed into circulation. <h3>Design, Setting,...
<h3>Importance</h3> A prior pilot study demonstrated the systemic absorption of 4 sunscreen active ingredients; additional studies are needed to determine ingredients and how quickly exposure exceeds 0.5 ng/mL as recommended by US Food Drug Administration (FDA). <h3>Objective</h3> To assess pharmacokinetics 6 (avobenzone, oxybenzone, octocrylene, homosalate, octisalate, octinoxate) in products under single- maximal-use conditions. <h3>Design, Setting, Participants</h3> Randomized clinical...
From Department of Medicine, Johns Hopkins University School Baltimore, Maryland. This paper is dedicated to the late A. McGehee Harvey, and Victor McKusick, John D. Stobo, David M. Hellmann, Edward J. Benz, Jr., Directors Medicine during career senior author (CJJ). Supported by grants from Eudowood Board (Hospital for Consumptives Maryland), Kaiser Family Fund, American Lung Association Maryland, Stetler Research Fund Women Physicians. Address reprint requests to: Dr. Carol Johns, Division...
Objective. To examine whether treatment of premature infants with intratracheal recombinant human CuZn superoxide dismutase (r-h CuZnSOD) reduces bronchopulmonary dysplasia and improves pulmonary outcome at 1 year corrected age. Design. Three hundred two (600–1200 g birth weight) treated exogenous surfactant for respiratory distress syndrome were randomized to receive either r-h CuZnSOD (5 mg/kg in 2 mL/kg saline) or placebo every 48 hours (as long as intubation was required) up month...
Chronic obstructive pulmonary disease (COPD) is a leading cause of death worldwide, and the rate COPD-related increasing.1 No current drug therapy alters progressive decline in lung function that characterizes this disease. In 2004, Food Drug Administration (FDA) approved use tiotropium delivered by HandiHaler device, first long-acting anticholinergic bronchodilator for treatment COPD. Trials supporting tiotropium's approval demonstrated sustained bronchodilation over 24-hour period. More...
ABSTRACT The sigF gene encodes an alternate sigma factor found in Mycobacterium tuberculosis and related pathogenic mycobacteria. Determination of conditions expression is important step understanding the conditional regulation which may govern such processes as virulence dormancy We constructed in-frame translational lacZ-kan fusion within to determine expression. This reporter construct was expressed from a multicopy plasmid strain BCG harboring integrated luciferase under control...
Objective Montelukast is a leukotriene receptor antagonist administered orally once daily for treatment of chronic asthma in adults and children. A comprehensive analysis safety data from double‐blind, randomized, placebo‐controlled trials with montelukast has not been previously reported. Patients methods pooled 11 multicentre, controlled Phase IIb III five long‐term extension studies was performed. total 3386 adult patients (aged 15–85 years) 336 paediatric 6–14 were enrolled the trials;...
In July, the FDA approved Arcapta Neohaler (indacaterol maleate powder), a long-acting beta-agonist, at daily dose of 75 μg for chronic obstructive pulmonary disease. Why was this selected, after European Medicines Agency 150-μg and 300-μg doses?
"Alcohol-based hand sanitizer exposures and effects on young children in the U.S. during COVID-19 pandemic." Clinical Toxicology, 59(4), pp. 355–356 AcknowledgementsAuthors thank S. Christopher Jones.Disclosure statementNo potential conflict of interest was reported by author(s).The views expressed are those authors not necessarily Food Drug Administration.
Summary Type I polyglandular autoimmune syndrome is characterized by the triad of hypoparathyroidism, Addison's disease and chronic mucocutaneous candidiasis. Chronic active hepatitis has been associated with this but its incidence severity have not well documented. We describe a sibship two patients type who presented hepatitis. The first patient to us advanced died despite an emergent liver transplant, while second responded steroids. Autoimmune hepatitis, major cause mortality in...
To augment the December 2010 United States Food and Drug Administration (FDA) Safety Communication on accidental ingestion of benzonatate in children less than 10 years old by summarizing data emergency department visits, exposure, reports overdoses from several sources.Retrospective review adverse-event drug utilization benzonatate.The FDA Adverse Event Reporting System (AERS) database (1969-2010), National Electronic Injury Surveillance System-Cooperative Project (NEISS-CADES, 2004-2009),...